Kornimate/medical-research-clean huggingface dataset:
evaluation of predictive factors for recurrence of persistent atrial fibrillation after ablation

Conditions: Atrial Fibrillation

Summary: this is a single-center, retrospective, observational study based on data extracted from the medical records of patients who underwent a procedure for persistent atrial fibrillation ablation.


Eligibility criteria:
inclusion criteria: * patient aged 18 years or older, who has been informed about the research * patient who underwent a procedure for persistent atrial fibrillation ablation at clairval hospital since january 2014 * patient for whom data regarding the ablation procedure are available exclusion criteria: * patient under legal protection, guardianship, or conservatorship * patient who has expressed opposition to the use of their medical data (by completing and returning the opt-out form provided)
immunogenicity and safety of a cell-derived influenza vaccine in elderly

Conditions: Influenza Vaccines

Summary: a controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.

this current phase ii study is to pursue objectives similar to those of the ongoing adult phase ii trial, but to expand into the elderly population who are more than 60 years of age. the results of this randomized, double blind, egg derived influenza vaccine (influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in europe. at study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. at start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.

Eligibility criteria:
inclusion criteria 1. willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. men and women (elderly) 3. being in good health as judged by medical history, physical examination and clinical judgment of the investigator. exclusion criteria 1. known to be allergic to constituents of the vaccine. 2. a serious adverse reaction after a previous (influenza) vaccination. presence of any significant condition that may prohibit inclusion as determined by the investigator. 3. having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Keywords: influenza active-controlled phase 2
safety and efficacy of daclatasvir (bms-790052) plus standard of care in japanese patients (pegylated-interferon alpha-2a and ribavirin)

Conditions: Hepatitis C Infection

Summary: the purpose of this study is to identify at least 1 dose of daclatasvir, that when combined with peginterferon-alfa (pegifnα) and ribavirin (rbv) for the treatment of chronically infected hcv genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious


Eligibility criteria:
key inclusion criteria: * subjects chronically infected with hepatitis c virus (hcv) genotype 1 * hcv rna viral load ≥ 10\*5\* iu/ml (100,000 iu/ml) at screening * the current standard of care naïve or non-responder key exclusion criteria: * cirrhosis * hcc * co-infection with hepatitis b virus (hbv), hiv-1 or hiv-2
whole body vibration training for healthy body composition in young adults

Conditions: Obesity; Weight Gain

Summary: the purpose of this study is to evaluate the benefits and feasibility of a whole body vibration (wbv) exercise program as a method of preventing weight gain in young adults.


Eligibility criteria:
inclusion criteria: 1. bmi that is between 22-29.9 kg/m2 2. history of being weight stable (± 2 kg) for three months prior to beginning the intervention 3. not currently on a prescribed diet plan to lose weight and no plan to begin one 4. not consistently engaged in physical activity that meets current public health recommendations of 150 minutes of moderate to vigorous physical activity in the previous 6 months 5. currently enrolled as an undergraduate student in a degree-granting college or university 6. planning to reside in the portland metro area for the duration of the study exclusion criteria: 1. health condition that would prevent participation in moderate intensity physical activity program. 2. for female participants, pregnancy or plans to become pregnant during the study period (source documentation: self-report on hhq) 3. currently smoking/tobacco products or initiation of smoking/tobacco during the study 4. alcohol consumption exceeding 3 drinks per day or a total of 18 drinks per week

Keywords: whole body vibration training young adult weight gain obesity randomized clinical trial
randomized study of osseotite certain tapered prevails vs. osseotite certain tapered

Conditions: Partial Edentulism; Tooth Disease

Summary: this study will demonstrate the benefits of platform switching design of the osseotite dental implant.

the osseotite certain prevail implant with its platform switch feature will demonstrate higher success rate than the non-platform osseotite certain implant

Eligibility criteria:
inclusion criteria: * patients of either sex and older than 18 years of age * patients needing at least one dental implant to treat partial edentulism * patients physically able to tolerate surgical and restorative dental procedures * patients agreeing to all protocol visits exclusion criteria: * patients with infection or severe inflammation at the intended treatment sites * patients smoking greater than 10 cigarettes per day * patients with uncontrolled diabetes mellitus * patients with uncontrolled metabolic diseases * patients who received radiation treatment to the head in the past 12 months * patients needing bone grafting at the intended treatment sites * patients known to be pregnant at screening visit * patients with para-functional habits like bruxing and clenching

Keywords: partial edentulism dental implants osseotite certain prevail tapered osseotite certain tapered crestal bone level randomized clinical study
fast mr for young children with traumatic brain injury

Conditions: TBI (Traumatic Brain Injury)

Summary: this proposal will test the diagnostic utility of fast magnetic resonance (mr) in young children with traumatic brain injury (tbi). in children, tbi causes \>2000 deaths, 35,000 hospitalizations and 470,000 emergency department visits in the us each year, making it a leading cause of pediatric disability and death. currently 20-50% of these children undergo computed tomography (ct) scanning, exposing them to harmful radiation, and increasing their lifetime risk of cancer. risks are especially increased in children because the neurologic exam is less reliable, because growing tissues are more vulnerable to radiation, and because children have more years to accumulate harmful mutations. fast mr is a short, motion-tolerant protocol that has been used in children with shunted hydrocephalus to eliminate radiation exposure without the need for sedation. however, fast mr has not been validated in children with tbi, a critical gap. the investigators will measure feasibility and diagnostic utility of fast mr in children \< 6 years (72 months) old who undergo head ct for tbi. the investigator will recruit children in whom a head ct is ordered for tbi. consenting subjects will undergo fast mr shortly after ct and results will be compared to determine: 1) whether fast mr identifies all traumatic injuries identified by ct and 2) whether fast mr without sedation can be performed quickly and successfully.


Eligibility criteria:
inclusion criteria: * children \<72 months old in whom a head ct is ordered/obtained with concerns for tbi * present to the children's hospital colorado (chco) emergency department (ed) or inpatient wards exclusion criteria: * contraindication to mr (e.g. pacemaker, implanted metallic object incompatible with mr) * prior diagnosis of tbi, structural brain lesion or prior brain surgery including shunted hydrocephalus * prior participation in this study * clinically unstable in the opinion of the patient's attending physician * wards of the state * tbi not included in the differential diagnosis of the patient's attending physician (e.g. the indication for imaging is concern for infections, tumor, autoimmune or inflammatory disease) or if imaging has already identified a non-traumatic source for symptoms
a study of pertuzumab with erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: this study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) who have failed on at least one prior chemotherapy regimen. the anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is less than 100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients greater than or equal to 18 years of age * histological confirmation of non-small cell lung cancer (nsclc) * locally advanced or metastatic disease * failure of at least one prior regimen of standard chemotherapy for locally advanced or metastatic disease * life expectancy of more than or equal to 12 weeks * eastern cooperative oncology group (ecog) performance status of 0-2 * baseline left ventricular ejection fraction (lvef) of greater than or equal to 50% * a negative pregnancy test one week prior to treatment and willingness to use contraception among women of childbearing potential * availability of histological formalin-fixed, paraffin-embedded (ffpe) tumor tissue exclusion criteria: * prior chemotherapy, radiotherapy or immunotherapy within 4 weeks of study day -8 * prior treatment with any agent which targets growth factors or their receptors * patients who have not recovered from the acute reversible effects of chemotherapy and radiotherapy * history of clinically significant cardiovascular disease * history or evidence of central nervous system metastases * treatment with any investigational drug within 28 days of the start of the study (day -8) * prior cumulative doxorubicin dose of more than 360 mg/m2 or the equivalent

Keywords: non-squamous
phase ii study of dcvac/pca added to standard chemotherapy for men with metastatic castration resistant prostate cancer

Conditions: Prostate Cancer; Prostate Cancer Metastatic

Summary: the purpose of this study is to determine whether dcvac/pca added onto standard of care therapy can improve survival times for patients with metastatic castration resistant prostate cancer


Eligibility criteria:
inclusion criteria: * men aged ≥ 18 years * histologically confirmed prostate cancer * presence of skeletal metastasis (by ct or pet or mri) * disease progression documented by increasing psa or two new lesions * eastern cooperative oncology group (ecog) performance status 0-2 exclusion criteria: * confirmed brain and/or leptomeningeal metastases * prior chemotherapy for prostate cancer * peripheral neuropathy of common toxicity criteria (ctc) grade 2 or greater * other uncontrolled intercurrent illness * treatment with immunotherapy against pca * clinically significant cardiovascular disease * active autoimmune disease requiring treatment

Keywords: immunotherapy metastatic castrate resistant prostate cancer biological vaccine
lung mri and allergic broncho-pulmonary aspergillosis in cystic fibrosis

Conditions: Pulmonary Cystic Fibrosis; ABPA

Summary: in this diagnostic study, the aim is at evaluating the diagnostic accuracy of mri (magnetic resonance imaging) to detect allergic broncho-pulmonary aspergillosis in patients with cystic fibrosis.

allergic broncho-pulmonary aspergillosis (abpa) is not rare in the context of cystic fibrosis (cf), with a prevalence reported between 2% to 16%. this complication is a diagnostic challenge for clinicians, since it is related with poorer outcome and higher worsening of the disease. therefore, the treatment relies on corticosteroid and antifungal therapy and thus, it is important to detect with good sensitivity because cf patients are usually treated with antibiotics. however, the treatment is often difficult to be initiated because of potential secondary side effects related to diabetes mellitus, growth impairment, bone mineralisation or immunodepression. therefore, there is a need for specific diagnostic tool to discriminate abpa amongst other polymicrobial infection. lung mri is a radiation-free imaging modality which offers the potential to combine several contrasts, in order to enable in vivo tissue characterization non-invasively. investigators hypothesize that characterization of mucoid impaction using lung mr t1-weighted and t2-weighted contrasts may be a specific tool to diagnose abpa in cf non invasively. additional information on functional information related to ventilation and/or perfusion will be assessed using functional mr sequences, to assess the severity of small airway impairment. moreover, the diagnostic value of structural alterations such as bronchiectasis, mucoid impaction and consolidation/atelectasis using either mri with ultrashort echo times or ct using reduction of doses down to chest radiograph levels will be assessed.

Eligibility criteria:
inclusion criteria: * cystic fibrosis proven by sweat chloride and genetic tests * age superior or equal to 6 year-old * diagnosis of abpa available on the basis of the criteria by cystic fibrosis foundation consensus conference * no contraindication to perform mri non-inclusion criteria: . age inferior to 6-year-old * cystic fibrosis not proven * abpa status not documented * mri contraindications: pregancy, magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants...), metal inside the eye or the brain (aneurysm clip, ocular foreign body not compatible with mri), cardiac valvular prothesis not compatible with mri, subject with claustrophobia. exclusion criteria: none
efficacy and safety of kn057 prophylaxis in patients with haemophilia a or b with inhibitors

Conditions: Hemophilia A With Inhibitor; Hemophilia B With Inhibitor

Summary: the purpose of this study is to show that kn057 can prevent bleeds in patients with haemophilia a or b with inhibitors and is safe to use. successfully screened participants will be randomly assigned to kn057 prophylaxis (arm 1) versus no prophylaxis (arm 2) at a ratio of 2:1. participants in kn057 prophylaxis will receive kn057 prophylaxis for 52 weeks upon enrollment. participants in no prophylaxis will first receive on-demand treatment for 26 weeks, then switch to kn057 prophylaxis for 26 weeks.the trial period is 59 weeks, including a 3-week screening period, a 26-week main trial, a 26-week extension period, and a 4-week follow-up period after the last administration.


Eligibility criteria:
inclusion criteria: 1. male, 12 to 70 years old at the time of signing informed consent (including the cut-off value), body weight ≥25 kg and bmi \<28 kg/m\^2 at screening; 2. the fviii or fix inhibitor test is positive at a high titer (≥5 bu/ml) during the screening period; or the fviii or fix inhibitor is detected at a low titer (0.6 bu/ml or the upper limit of normal value \< inhibitor titer \< 5 bu/ml) during the screening period and treatment with bypass agents (rfviia or pcc) has been started; 3. ≥6 treated bleeding episodes within 26 weeks before screening; 4. have not used tfpi antibody drugs before; 5. be able and agree to elute prior drugs for the treatment of hemophilia. exclusion criteria: 1. have serious or poorly controlled chronic diseases or obvious systemic diseases; 2. have a history of thromboembolic disease, or currently have symptoms or signs related to thromboembolic disease or being treated with thrombolytic/antithrombotic therapy; 3. have high-risk factors for thrombosis: such as a history of coronary atherosclerotic disease, ischemic disease of important organs, vascular occlusive disease, autoimmune diseases with a high risk of thrombosis, or indwelling central venous catheter; 4. the presence of other inherited or acquired bleeding disorders other than hemophilia a and hemophilia b; 5. being on standard prophylaxis and maintaining it for more than 12 weeks (standard prophylaxis is defined as at least 80% compliance with a predetermined prophylaxis regimen); 6. ongoing or planned immune tolerance induction treatment; 7. when bleeding occurred in the past, rfviia was ineffective and pcc treatment must be used; 8. known or suspected hypersensitivity to any constituent of the trial product or related products; 9. have undergone major surgery (as determined by the investigator) within 3 months before screening, or have elective surgery planned during the study.
impact of anesthesiology interventions on postoperative outcomes in adult patients undergoing shoulder surgery

Conditions: Postoperative Complications

Summary: this retrospective, population-based cohort study will evaluate the comparative effectiveness of peripheral nerve blocks on patient outcomes after ambulatory shoulder surgery in adults patients undergoing surgery in ontario.

first, investigators will validate health administrative data codes to demonstrate the accuracy of ontario-wide anesthesia type and regional anesthesia interventions using a reference standard (ottawa hospital data warehouse data). then, these validated exposures, in combination with validated outcome measures, will be used to examine the impact of anesthesia interventions on patient and health system outcomes for ambulatory shoulder surgery.

Eligibility criteria:
inclusion criteria: * ontario residents * aged 18 years and older * elective ambulatory shoulder surgery performed in ontario between april 2009 and december 2016. exclusion criteria: * emergency surgery * if a patient undergoes multiple elective shoulder surgeries within the time period, only the first surgery will be included for any participant in the study period.
biological and behavioral outcomes of community nature walks

Conditions: Stress, Psychological; Telomere Shortening; Stress Reaction

Summary: the investigators will test the efficacy of our proposed intervention to reduce embodied stress in four racial/ethnic groups (black, latinx, pilipinx, and pacific islander) as a preventative intervention for health disparities found in these communities. the intervention is comprised of two phases. the first consists of community nature walks in a pristine redwood forest for six months. this is followed by chosen nature activities with family and/or friends for three months. the investigators will test the ability of these activities in nature to reduce chronic stress that underpins many health disparities using validated biological, behavioral, and sociocultural measures. the use of these measures is in alignment with the national institute of minority health and health disparities (nimhd) research framework, and will increase understanding of individual, interpersonal, community, and social level factors that lead to, and that can eliminate health disparities.

the investigators will test the efficacy of our proposed intervention to reduce embodied stress in four racial/ethnic groups (black, latinx, pilipinx, and pacific islander) as a preventative intervention for health disparities found in these communities. the intervention is comprised of two phases. the first consists of community nature walks in a pristine redwood forest for six months. this is followed by chosen nature activities with family and/or friends for three months. the investigators will test the ability of these activities in nature to reduce chronic stress that underpins many health disparities using validated biological, behavioral, and sociocultural measures. the use of these measures is in alignment with the national institute of minority health and health disparities (nimhd) research framework, and will increase understanding of individual, interpersonal, community, and social level factors that lead to, and that can eliminate health disparities.

Eligibility criteria:
inclusion critieria: * 18 years or older * able to commit to a 9-month nature intervention (6-month walks; 3-month chosen nature activity) * spoken languages: english, spanish, or tagalog * able-bodied as in must be able to walk. exclusion criteria: * pregnant women (and other gender identities who are pregnant) * prisoners * cognitively impaired
incidence of superficial vein thrombosis

Conditions: Superficial Vein Thrombosis

Summary: to date, the investigators still do not know the annual incidence of superficial vein thrombosis in the legs, although the investigators do know that this pathology is frequent and the investigators can assume its incidence is greater than deep vein thrombosis which is of 1 to 2 cases per year per 1,000 inhabitants. furthermore, the high percentage of svt with concomitant dvt and pulmonary embolism only concerns patients seen in vascular medicine, so it is important to re-evaluate this rate on an unselected population from general practice.

the method is a prospective observational study involving all the general practitioners and vascular physicians of the saint etienne region, i.e. 276 general practitioners, 27 vascular physicians and 341,822 inhabitants. any new case of symptomatic svt in the legs suspected by the general practitioner and confirmed by compression ultrasonography by the vascular physician would be listed over one year. the confirmed svts, directly seen by the vascular physicians would also be listed. the incidence would be calculated by relating the total number of svts observed to the number of inhabitants of the saint etienne region. information on whether concomitant dvt exists or not at the time of the compression ultrasonography would also be collected.

Eligibility criteria:
inclusion criteria: * inhabitants of the saint etienne region * with suspected svt * consulting general practitioners and or vascular physicians of the saint etienne region exclusion criteria: * svt not confirmed by compression ultrasonography

Keywords: superficial vein thrombosis saint etienne region
the influence of movement velocity biofeedback on muscle activation and self perception in older adults with sarcopenia

Conditions: Sarcopenia; Sarcopenia in Elderly; Age-associated Muscle Loss

Summary: the overall objective for this clinical trial is to provide evidence for internal and external cueing for physical therapists and other rehabilitation clinicians to optimize resistance training within rehabilitation for older adults. the main questions it aims to answer are: * what is the impact of external focus (providing velocity of movement for each repetition) compared to internal focus (i.e., no cues, control group) on physical percent velocity loss and neuromuscular activation in older adults with sarcopenia? * does internal and external focus influence motivation and perceptual workload following resistance training in older adults with sarcopenia? researchers will compare external focus to internal focus to see if external focus impacts percent velocity loss, motivation, and perceived workload. participants will: * visit the lab once per week for 3 weeks * perform exercise testing using a leg press * answer questionnaires regarding perceived workload and motivation before and after exercise


Eligibility criteria:
inclusion criteria: * community-dwelling older adults 60-95 years of age * physically independent * free of severe mental impairment * score 4 or greater on the sarc-f sarcopenia questionnaire exclusion criteria: * participated in a structured resistance training program in the last 12 months * had a lower extremity injury or surgical intervention within the past 6 months * have neuromuscular (i.e., parkinson's disease, multiple sclerosis), circulatory, or edema pathology

Keywords: geriatrics neuromuscular rehabilitation sarcopenia velocity-based training